BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 5388712 · Received January 25, 2016

    Report

    Report Number
    1219930-2016-00063
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    December 21, 2015
    Report Date
    January 7, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    LJS
    PMA / PMN Number
    K961856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN THE DOCTOR OPENED THE PRODUCT, HE FOUND THE SHEATH WAS ALREADY BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47270 2PC VSYS W/9FR INTR KIT LW PFL CATHETER INTRODUCER KIT LJS COVIDIEN, FORMERLY US SURGICAL A DIVISON 120021 N2K0186X

    Patients

    Seq Age Sex Outcome Treatment
    1